title: Dronabinol in severe, enduring anorexia nervosa: a randomized controlled trial.
abstract: OBJECTIVE
  The evidence for pharmacological treatment of severe, longstanding anorexia nervosa (AN) is sparse and the few controlled pharmacologic studies have focused on a narrow range of drugs. The aim of the present study was to investigate the effects of treatment with a synthetic cannabinoid agonist on body weight and eating disorder-related psychopathological personality traits in women with severe, enduring AN.
  
  
  METHODS
  This add-on, prospective, randomized, double blind, controlled crossover study was conducted between 2008 and 2011 at a specialized care center for eating disorders. Twenty-five women over 18 years with AN of at least 5 years duration were randomized to treatment with either dronabinol-placebo or placebo-dronabinol. In addition to the standardized baseline therapeutic regime, the participants received dronabinol, 2.5 mg twice daily for 4 weeks and matching placebo for 4 weeks, separated by a 4-week wash-out period. Primary outcome was the mean change in body weight. Secondary outcome was score changes on the Eating Disorder Inventory-2 (EDI-2). Data were analyzed for the 24 patients who completed the trial.
  
  
  RESULTS
  During dronabinol treatment, participants gained 0.73 kg (t = 2.86, df = 22, p < 0.01) above placebo without significant psychotropic adverse events. Dronabinol significantly predicted weight gain in a multiple linear regression including EDI-2 body dissatisfaction score and leptin. EDI-2 subscale scores showed no significant changes over time.
  
  
  CONCLUSIONS
  Dronabinol therapy was well tolerated. During four weeks of exposure it induced a small but significant weight gain in the absence of severe adverse events.
authors.affiliation: Center for Eating Disorders, Department of Endocrinology, Odense University Hospital, DK-5000, Odense C, Denmark.
authors.forename: Alin
authors.initials: A
authors.lastname: Andries
authors.forename: Jan
authors.initials: J
authors.lastname: Frystyk
authors.forename: Allan
authors.initials: A
authors.lastname: Flyvbjerg
authors.forename: René Klinkby
authors.initials: RK
authors.lastname: Støving
mesh_terms: D000328:Adult; D000856:Anorexia Nervosa / Q000188:drug therapy* / Q000209:etiology / Q000534:rehabilitation; D001835:Body Weight / Q000187:drug effects*; D063386:Cannabinoid Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D003718:Denmark; D004311:Double-Blind Method; D013759:Dronabinol / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D018529:Nutritional Support; D011446:Prospective Studies; D016896:Treatment Outcome; D015430:Weight Gain
chemical_list: D063386:Cannabinoid Receptor Agonists; D013759:Dronabinol
keywords: anorexia nervosa; cannabinoid; dronabinol; eating disorder inventory; leptin; weight